An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC

NCT07669610 | Not Yet Recruiting Phase 3

• 1 other identifier: SCHBCC-N0116
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.

Conditions

Breast Cancer; Triple Negative Breast Cancer (TNBC)

Keywords

triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival(PFS)

  Time to progressive disease (according to RECIST1.1)

  24 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  24 months

• Duration of Response (DoR)

  24 months

• Disease Control Rate (DCR)

  24 months

• Overall survival (OS)

  24months

• Safety and Tolerability

  24months

Study Arms (2)

Arm-A

EXPERIMENTAL

SHRA1811 at 4.8 mg/kg in combination with BP102 at 15 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.

Drug: SHR-A1811+BEV

Arm-B

ACTIVE COMPARATOR

SHRA1811 at 4.8 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.

Drug: SHR- A1811

Interventions

SHR-A1811+BEV DRUG

SHRA1811(HER-targeted ADC) at 4.8 mg/kg in combination with BEV(bevacizumab) at 15 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.

Also known as: Trastuzumab Rezetecan；bevacizumab

Arm-A

SHR- A1811 DRUG

SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle.

Also known as: Trastuzumab Rezetecan

Arm-B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥18 years and ≤70 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
• Life expectancy of at least 3 months;
• Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \[ER\], progesterone receptor \[PR\], and human epidermal growth factor receptor 2 \[HER-2\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \<1%; PR-negative: IHC \<1%; HER2-negative: IHC -/+ or IHC ++ with FISH/CISH negative. All specimens must be verified as the BLIS subtype of the Fudan quadruple molecular classification by the Precision Medicine Center/Department of Pathology at the study's participating center);
• Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;
• Patients must have at least one lesion (measurable and/or non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT/MRI, and can be repeatedly evaluated according to RECIST 1.1;
• Adequate major organ function, meeting the following criteria:
• Hematological parameters: hemoglobin (HB) ≥90 g/L (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥75×10⁹/L;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \>50 mL/min (Cockcroft-Gault formula);
• No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;
• Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;
• Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

You may not qualify if:

• Patients with any of the following criteria will be excluded from this study:
• Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;
• History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
• Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;
• Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;
• Pregnant or lactating patients;
• Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
• Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;
• Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;
• Long-term unhealed wounds or incompletely healed fractures;
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU/mL, or chronic hepatitis with abnormal liver function;
• History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;
• History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;
• Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \>1.0 g;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhimin Shao

CONTACT

02164175590; zhimingshao@yahoo.com

Yin Liu

CONTACT

02164175590; liuyinfudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06